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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00062803




Registration number
NCT00062803
Ethics application status
Date submitted
16/06/2003
Date registered
17/06/2003
Date last updated
29/04/2009

Titles & IDs
Public title
SR34006 Compared to Vitamin K Antagonist (VKA) in the Treatment of Pulmonary Embolism
Scientific title
The Van Gogh-PE Trial, a Multicenter, International, Randomized, Open-Label, Assessor-Blind, Non-Inferiority Study Comparing the Efficacy and Safety of Once-Weekly Subcutaneous SR34006 With the Combination of (LMW)Heparin and Vitamin K Antagonist (VKA) in the Treatment of Acute Symptomatic Pulmonary Embolism
Secondary ID [1] 0 0
EFC3484
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Embolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SR34006
Treatment: Drugs - (LMW)heparin
Treatment: Drugs - Warfarin VKA
Treatment: Drugs - Acenocoumarol VKA

Treatment: Drugs: SR34006


Treatment: Drugs: (LMW)heparin


Treatment: Drugs: Warfarin VKA


Treatment: Drugs: Acenocoumarol VKA
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
symptomatic recurrent PE/DVT within 6 months.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
- Confirmed acute symptomatic Pulmonary Embolism (PE) with or without concomitant Deep
Vein Thrombosis (DVT)

- Written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Legal lower age limitations (country specific)

- Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the
current episode of PE

- Other indication for VKA than PE/DVT

- More than 36 hours pre-randomization treatment with therapeutic dosages of
(LMW)heparin or initiation of VKA treatment prior to randomization

- Participation in another pharmacotherapeutic study within the prior 30 days

- Creatinine clearance <10 mL/min, severe hepatic disease, or bacterial endocarditis

- Life expectancy <3 months

- Active bleeding or high risk for bleeding

- Uncontrolled hypertension: systolic blood pressure >180 mm Hg or diastolic blood
pressure >110 mm Hg

- Pregnancy or childbearing potential without proper contraceptive measures or women who
are breastfeeding

- Any other contraindication listed in the labeling of warfarin, acenocoumarol,
unfractionated heparin, enoxaparin, or tinzaparin

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2005
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Box Hill, Clayton, Garran, Kogarah, Ringwood East
Recruitment hospital [2] 0 0
- St. Leonards, South Australia
Recruitment postcode(s) [1] 0 0
- Box Hill, Clayton, Garran, Kogarah, Ringwood East
Recruitment postcode(s) [2] 0 0
- St. Leonards, South Australia
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
New Mexico
Country [12] 0 0
United States of America
State/province [12] 0 0
New York
Country [13] 0 0
United States of America
State/province [13] 0 0
North Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
North Dakota
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Virginia
Country [23] 0 0
United States of America
State/province [23] 0 0
Washington
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Austria
State/province [25] 0 0
Graz
Country [26] 0 0
Belgium
State/province [26] 0 0
Bruxelles, Charleroi, Leuven, Liege, Yvoir
Country [27] 0 0
Brazil
State/province [27] 0 0
Goiania, Porto Alegre, Sao Paulo, Salvador
Country [28] 0 0
Canada
State/province [28] 0 0
Alberta
Country [29] 0 0
Canada
State/province [29] 0 0
British Columbia
Country [30] 0 0
Canada
State/province [30] 0 0
Manitoba
Country [31] 0 0
Canada
State/province [31] 0 0
Nova Scotia
Country [32] 0 0
Canada
State/province [32] 0 0
Ontario
Country [33] 0 0
Canada
State/province [33] 0 0
Quebec
Country [34] 0 0
Czech Republic
State/province [34] 0 0
Brno, Jihlava, Karlovy Vary, Kladno, Ostrava Poruba, Prague
Country [35] 0 0
Czech Republic
State/province [35] 0 0
Plzen
Country [36] 0 0
Denmark
State/province [36] 0 0
Arhus, Frederiksberg, Glostrup, Hillerod, Kobenhavn, Odense
Country [37] 0 0
Denmark
State/province [37] 0 0
Roskilde
Country [38] 0 0
Finland
State/province [38] 0 0
Hus, Jyvaskyla, Seinajoki, Turku
Country [39] 0 0
France
State/province [39] 0 0
Armentieres, Besancon, Bethune, Brest, Chambray Les Tours
Country [40] 0 0
France
State/province [40] 0 0
Clamart, Lens, Lille, Nice, Nimes, Paris, Rennes, Roubaix
Country [41] 0 0
France
State/province [41] 0 0
Saint Malo, Valenciennes
Country [42] 0 0
France
State/province [42] 0 0
Tourcoing
Country [43] 0 0
Germany
State/province [43] 0 0
Augsburg, Berlin, Bochum, Dresden, Garmisch-Partenkirchen
Country [44] 0 0
Germany
State/province [44] 0 0
Heidelberg, Ibbenburen, Mannheim, Munchen
Country [45] 0 0
Italy
State/province [45] 0 0
Cremona, Fidenza, Genova, Lecco, Milano, Padova, Parma, Pavia
Country [46] 0 0
Italy
State/province [46] 0 0
Piacenza, Pisa, Reggio Emilia, Treviso, Venezia
Country [47] 0 0
Netherlands
State/province [47] 0 0
Alkmaar, Amersfoort, Amsterdam, Breda, Gouda, Groningen
Country [48] 0 0
Netherlands
State/province [48] 0 0
Haarlem, Maastricht, Nieuwegein
Country [49] 0 0
Norway
State/province [49] 0 0
Oslo, Rud
Country [50] 0 0
Poland
State/province [50] 0 0
Lublin, Warszawa, Wroclaw
Country [51] 0 0
Spain
State/province [51] 0 0
Badalona, Madrid, Sevilla
Country [52] 0 0
Sweden
State/province [52] 0 0
Goteborg, Jonkoping, Stockholm, Varnamo
Country [53] 0 0
Switzerland
State/province [53] 0 0
Basel, Bern, Lugano
Country [54] 0 0
United Kingdom
State/province [54] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Patients who have a pulmonary embolism (blood clot in the lung) will be treated in this
study. The purpose of the study is to compare the safety and effectiveness of a new
injectable anticoagulant (blood-thinning) drug, SR34006, with the standard way of treating a
pulmonary embolism. The standard treatment includes injections or infusions of an
anticoagulant drug, (LMW)heparin, for about a week followed by anticoagulant tablets
(warfarin or acenocoumarol) which are taken by mouth.

Assignment to either SR34006 or (LMW)heparin plus warfarin or acenocoumarol will be purely by
chance and will be known by both patients and their doctors.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00062803
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00062803